Guidelines on the Stability Evaluation of Vaccines for Use under Extended Controlled Temperature Conditions. WHO Expert Committee on Biological Standardization, Sixty-sixth Report; WHO Technical Report Series No. 999, 2016, Annex 5
(2016; 30 pages)

Abstract

Vaccines are complex biological products and may undergo degradation during long-term storage under cold chain conditions (for example, 2–8 °C) and this is typically enhanced at higher temperatures. Consequently, establishing the stability characteristics of products is a critical element of the overall evaluation by a national regulatory authority (NRA) to ensure that licensed vaccines remain efficacious at the end of their shelf-life when stored under the approved conditions. In response to the stability assessment needs identified by NRAs, WHO developed guidelines on the stability evaluation of vaccines to assist its Member States. While it is well understood that vaccine quality depends on cold chain storage, it is also recognized that immunization programmes incertain regions face substantial challenges in maintaining cold chains in the field, especially during the final stage of distribution in remote areas. To address these distribution challenges and expand immunization programmes into specific regions WHO developed a “controlled temperature chain” (CTC) programme. This programme currently requires that a vaccine exhibits a stability profile suitable for a single exposure to at least 40 °C for a minimum of 3 days just prior to administration, while remaining compliant with the approved vaccine specifications. Additionally, the programme requires that the CTC provision should be included in the licensure by the relevant NRA and by WHO prequalification.

This document provides guidance to NRAs and manufacturers on the scientific and regulatory issues to be considered in evaluating the stability of vaccines for use under ECTC. Evaluation criteria are provided for the approval of short-term temperature conditions, in addition to those defined for long-term storage of a given vaccine, in situations where the vaccine is exposed to these short-term conditions immediately prior to administration.

This document does not provide guidance on the stability evaluation of vaccines that are inadvertently or repeatedly exposed to temperatures for which they were not licensed.

 
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